Up to 10 August 2021, Swissmedic evaluated 5,304 reports on suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland. The majority of the reports involved more than one reaction. At 3,466 (65.3 %), most of the reports were classified as not serious, while 1,838 (34.7 %) reports were classified as serious.
Most of the reports were submitted by medical professionals, while a relatively large number (1,612, or 30.4 %) came directly from those affected, i.e. the patients.
The average age of those affected was 57.7 years (range 16–101), with 21.9% aged 75 or over. In the cases classified as serious, the average age was 61.3 years, and for reports temporally linked to a death it was 80.7 years. In 133 serious cases, the people concerned died at differing intervals after receiving the vaccine. Despite a chronological correlation, there is no concrete evidence to suggest that the vaccination was the cause of death.
The majority of the reports concerned women and there were a few cases where no gender was specified.
3,279 (61.8 %) reports involve Moderna's COVID-19 vaccine, while 1,934 (36.5 %) are associated with Pfizer/BioNTech’s Comirnaty®. In 91 (1.7%) cases, the vaccine was not specified.
| Vaccine | Total reports | of which non-serious | of which serious | Total vaccine doses * | Number of fully vaccinated people * |
|---|---|---|---|---|---|
| COVID-19 Vaccine Moderna® (Spikevax) | 3'279 (61,8 %) | 2'292 (66,13 %) | 987 (53,7 %) | 6'128'244 | 2'835'251 |
| Comirnaty® (Pfizer/BioNTech) | 1'934 (36,5 %) | 1'133 (32,69 %) | 801 (43,6 %) | 3'080'898 | 1'439'958 |
| Unknown | 91 (1,7%) | 41 (1,18 %) | 50 (2,7 %) | ||
| Total | 5'304 (100%) | 3'466 (100 %) | 1'838 (100 %) | 9'209'142 | 4'275'209 |
* Switzerland and Principality of Liechtenstein, 21.12.2020 - 10.08.2021 (Source: FOPH)
Organ systems most frequently affected
| Reaction (MedDRA) | |
|---|---|
General disorders and administration site conditions (10018065) |
4 152 |
Nervous system disorders (10029205) |
1 201 |
Skin and subcutaneous tissue disorders (10040785) |
985 |
Musculoskeletal and connective tissue disorders (10028395) |
836 |
Gastrointestinal disorders (10017947) |
604 |
Infections and infestations (10021881) |
363 |
Respiratory, thoracic and mediastinal disorders (10038738) |
280 |
Reproductive system and breast disorders (10038604) |
232 |
Cardiac disorders (10007541) |
215 |
Vascular disorders (10047065) |
188 |
Blood and lymphatic system disorders (10005329) |
116 |
Psychiatric disorders (10037175) |
115 |
Immune system disorders (10021428) |
98 |
Eye disorders (10015919) |
90 |
Ear and labyrinth disorders (10013993 |
66 |
Most frequent adverse effects
| Reported prefered terms (MedDRA) | |
|---|---|
Pyrexia (10037660) |
756 |
Headache (10019211) |
584 |
Injection site erythema (10022061) |
534 |
Fatigue (10016256) |
462 |
Skin reaction (10040914) |
435 |
Chills (10008531) |
429 |
Myalgia (10028411) |
369 |
Injection site pain (10022086) |
314 |
Nausea (10028813) |
242 |
Injection site swelling (10053425) |
239 |
Arthralgia (10003239) |
230 |
Injection site pruritus (10022093) |
208 |
Herpes zoster (10019974) |
207 |
Dizziness (10013573) |
168 |
Rash (10037844) |
155 |
Organ systems most frequently affected
| Reaction (MedDRA) | |
|---|---|
General disorders and administration site conditions (10018065) |
1318 |
Nervous system disorders (10029205) |
779 |
Musculoskeletal and connective tissue disorders (10028395) |
466 |
Skin and subcutaneous tissue disorders (10040785) |
321 |
Gastrointestinal disorders (10017947) |
320 |
Infections and infestations (10021881) |
318 |
Respiratory, thoracic and mediastinal disorders (10038738) |
249 |
Vascular disorders (10047065) |
158 |
Cardiac disorders (10007541) |
121 |
Immune system disorders (10021428) |
93 |
Reproductive system and breast disorders (10038604) |
86 |
Blood and lymphatic system disorders (10005329) |
75 |
Psychiatric disorders (10037175) |
69 |
Eye disorders (10015919) |
62 |
Ear and labyrinth disorders (10013993) |
57 |
Most frequent adverse effects
| Reported prefered terms (MedDRA) | |
|---|---|
Headache (10019211) |
331 |
Pyrexia (10037660) |
264 |
Fatigue (10016256) |
232 |
Myalgia (10028411) |
196 |
Chills (10008531) |
165 |
Herpes zoster (10019974) |
163 |
Nausea (10028813) |
120 |
Dizziness (10013573) |
115 |
Arthralgia (10003239 |
108 |
Injection site pain (10022086) |
83 |
Rash (10037844) |
79 |
Malaise (10025482) |
74 |
Dyspnoea (10013968) |
67 |
Hypersensitivity (10020751) |
56 |
Vomiting (10047700) |
55 |
The reports of adverse reactions received and analysed to date do not alter the positive benefit-risk profile of the COVID-19 vaccines used in Switzerland. This largely confirms their known side effects profile. Known side effects of COVID-19 vaccines are listed in the continually updated medicinal product information texts published on www.swissmedicinfo.ch.
The reports of suspected adverse drug reactions (ADR) to COVID-19 vaccinations are evaluated in collaboration with the regional pharmacovigilance centres and in particular with the Ticino reference centre (EOC cantonal hospital authority).
The next report of suspected adverse reactions of COVID-19 vaccines in Switzerland will be released on 3 September 2021.
You can find the latest report on suspected adverse reactions to COVID-19 vaccines in Switzerland at the following permalink: www.swissmedic.ch/covid-19-vaccines-safety-update-en
Myocarditis (inflammation of the heart muscle) / pericarditis (inflammation of the pericardium)
Very rare cases of myocarditis and pericarditis (inflammation of the heart muscle/pericardium) have been reported following vaccination with the COVID-19 mRNA vaccines. To date, Swissmedic has received 96 reports for approximately 9.2 million doses administered (for comparison: the frequency of myocarditis due to other causes such as viruses is listed as approximately 22 cases per 100,000 people per year). Cases in connection with COVID-19 vaccines generally occur within 14 days of vaccination and more frequently after the second dose and in younger men.
After evaluating all available data, there is at least a possible causal link between the vaccines and myocarditis/pericarditis. Healthcare professionals should pay attention to the signs and symptoms of myo-carditis and pericarditis and inform vaccinated people that they should seek immediate medical advice and assistance in the event of chest pains, shortness of breath or palpitations. Strong physical exertion should be avoided if such symptoms occur until the cause of the symptoms has been ascertained.
